Japanese encephalitis (JE) is the most common viral encephalitis, with over 50,000 cases reported annually. It is a considerable public health problem for many Asian countries (WHO 1997). Close to 3 billion people now live in regions at risk for the disease, particularly in rural areas where JE occurs sporadically in epidemics of variable magnitude. Vaccination against JE remains the single most important control measure worldwide.
Conditions
Interventions
Product Name: Japanese Encephalitis Purified Inactivated Vaccine
Product Code: IC51 (JE-PIV)
Pharmaceutical Form: Injection*
Trade Name: JE-VAX
Product Name: JE-VAX
Pharmaceutical Form: Injection*
Ph
Sponsors
Intercell AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - At least 18 years of age - In female subjects either childbearing potential terminated by surgery or one year post-menopausal, or a negative serum pregnancy test during screening and the willingness not to become pregnant during the study period and 30 days after the last vaccination by practicing reliable methods of contraception as specified in section 6.4 - Written informed consent obtained prior to study entry (subjects should give their consent themselves. Consent by legal representatives is allowed.) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - History of clinical manifestation of any flavivirus infection - History of vaccination against Japanese encephalitis (JE), Yellow fever and Dengue fever (an anti-JEV neutralizing antibody titer ³ 1:10 at baseline is acceptable for inclusion, these subjects will be part of the safety population, but will not be analyzed for immunogenicity in the per-protocol analysis) - Use of any investigational or non-registered drug or vaccine other than the study vaccine during the study period or within 30 days preceding the first dose of study vaccine - Planned administration of another vaccine during the study period - Immunodeficiency including post-organ-transplantation or immunosuppressive therapy - A family history of congenital or hereditary immunodeficiency - History of autoimmune disease - Administration of chronic (defined as more than 14 days) immunosuppressants or other immune-modifying drugs within six months of vaccination. (For corticosteroids, this will mean prednisone, or equivalent, ³ 0.5 mg/kg/day. Topical and inhaled steroids are allowed.) - Any acute infections within 4 weeks prior to enrollment - History of severe hypersensitivity reactions, anaphylaxis or severe cases of atopy requiring emergency treatment or hospital admission - Infection with HIV (a negative test result within 30 days before enrollment is acceptable), Hepatitis B (HBsAg) or Hepatitis C - History of urticaria after hymenoptera envenomation, drugs, physical or other provocations, or of idiopathic cause - Drug addiction within 6 months prior to enrollment (including alcohol dependence, i.e. more than approx. 60 g alcohol per day, or conditions which might interfere with the study conduct) - Known hypersensitivity to thimerosal - Diabetes mellitus in subjects receiving insulin therapy, severe cardiopulmonary disorders, history of malignancy in the past 5 years -Subjects with any condition which in the opinion of the investigator makes the subject unsuitable for inclusion - Pregnancy (positive pregnancy test during screening or at baseline), lactation or unreliable contraception in female subjects (for details please refer to protocol section 6.4) - Inability or unwillingness to provide informed consent and to abide by the requirements of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the non-inferiority of IC51 (JE-PIV) (2 x 6 mcg) compared to JE-VAX® (3 x 1.0 mL) Japanese encephalitis vaccine in terms of the seroconversion rate (SCR) and geometric mean antibody titers (GMT) at day 56; 4 weeks after the last vaccination ;Secondary Objective: To compare - the superiority of IC51 (JE-PIV) vs. JE-VAX® seroconversion rate and GMT at day 56, provided that non-inferiority has been demonstrated - the immunogenicity of both vaccines in regards to SCR and GMTs of the North American with the European / South African study population - the immunogenicity of both vaccines in regards to SCR and GMTs in subjects older vs. younger than 50 years of age - the safety profile of IC51 (JE-PIV) vs. JE-VAX® ;Primary end point(s): SCR (anti-JEV neutralizing antibody titer ³ 1:10) and GMT at day 56 for the global study population | — |
Countries
Austria
Outcome results
None listed